Cleared Traditional

Infinitt PACS 7.0

K172803 · Infinitt Healthcare Co., Ltd. · Radiology

Oct 2017

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K172803 is an FDA 510(k) clearance for the Infinitt PACS 7.0, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Infinitt Healthcare Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on October 27, 2017, 39 days after receiving the submission on September 18, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K172803 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2017
Decision Date	October 27, 2017
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF